Population Pharmacokinetics of Amoxicillin in Neonates (NEOPOPI)
|ClinicalTrials.gov Identifier: NCT03987100|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.
There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.
|Condition or disease|
- Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
- Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
- Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
- Population pharmacokinetic analysis
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose|
|Actual Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
- Achievement rate of therapeutic efficacy target of amoxicillin [ Time Frame: 1 week ]Achievement rate of therapeutic efficacy target of amoxicillin (ie percentage of neonates in whom amoxicillin plasma concentration remains above the MIC of target organisms for more than 70% of the dose range). In accordance with the recommendations of the European Medicines Agency, the optimal dosage regimen is defined as leading to a probability of antibiotic therapy success of greater than or equal to 90%. Thus, it is necessary to determine the dosage regimen allowing the target of therapeutic efficacy to be reached (ie maintenance of the plasma concentration of amoxicillin greater than the MIC of the targeted microorganisms for more than 70% of the dose) in at least 90% of treated neonates.
- Recording of Adverse Events [ Time Frame: 1 week ]Recording of adverse events (clinical and / or biological) during the treatment period and up to 96 hours after the end of treatment
- Minimum Inhibitory Concentration [ Time Frame: 1 week ]Collection of MICs of amoxicillin for isolated germs. For amoxicillin the antibacterial activity is time-dependent, the predictor of efficacy is the "Time> MIC": this is the percentage of the administration interval during which the concentration of the antibiotic remains higher than the MIC of target germs
- Concentration of amoxicilin in Cerebrospinal Fluid (CSF) [ Time Frame: 1 week ]Calculation of amoxicillin concentration in CSF / amoxicillin plasma concentration when data permits (i.e. when lumbar puncture is performed as part of usual care, during treatment with amoxicillin
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987100
|Contact: Stuart Byrom||0033 (0)299284312||stuart.BYROM@chu-rennes.fr|
|Contact: Stephanie Leroux, Phd||0033 (0)299284312||Stephanie.LEROUX@chu-rennes.fr|
|Rennes, France, 35000|
|Contact: Stuart Byrom 0033 (0)299284312 firstname.lastname@example.org|